NASHVILLE, Tenn., March 26, 2018 /PRNewswire/ -- Cumberland
Pharmaceuticals Inc. (NASDAQ: CPIX), a U.S. specialty
pharmaceutical company announced today the publication of an open
access article in Infection and Drug Resistance, with
results demonstrating an 85% eradication rate of Helicobacter
pylori (H. pylori) infection using clarithromycin-based triple
therapy. Cumberland markets a
branded clarithromycin-based triple therapy in the U.S. under the
name Omeclamox®-Pak.
H. pylori has long been known as a common pathogen associated
with gastric ulcers and related dyspeptic symptoms in many infected
patients. If H. pylori is left untreated, it can damage the stomach
and small intestine wall causing peptic ulcer disease, specifically
duodenal ulcers. Symptoms of H. pylori-induced duodenal ulcers
generally surface in adults and may include burning pain in the
abdomen, nausea, vomiting, bloating, and weight loss.
Currently, the use of clarithromycin-based triple therapy has
the support of organizational bodies in gastroenterology. Over the
last 10 years, early recommendations to use clarithromycin-based
triple therapy have been challenged by some sources and based on
the premise that resistance is increasing.
This study, led by Devjit S.
Nayar at Gastroenterology Associates of Central Jersey,
evaluated the potential incidence of resistance in the New York Metropolitan region. The clinical
success rate of clarithromycin-based triple therapy was evaluated
by retrospectively reviewing patient data over six years. The cases
of 151 patients, ranging in age from 21–76 years and receiving
prescriptions for clarithromycin-based triple therapy between
December 2011 and May 2017 were analyzed. The results of H. pylori
eradication testing following completion of clarithromycin-based
triple therapy revealed that 85%, or 130 of the 151, patients
treated according to the standard protocol were negative for H.
pylori.
Despite predictions from other sources in the last decade that
clarithromycin-based treatments are becoming less effective, based
on the results of this study, patients with a positive diagnosis of
H. pylori could expect an 85% or better eradication rate when
treated with clarithromycin-based triple therapy.
About Omeclamox®-Pak (omeprazole, clarithromycin,
amoxicillin)
Omeclamox®-Pak is indicated for the treatment of
patients with H. pylori infection and duodenal ulcer disease to
eradicate H. pylori. Omeprazole is an antisecretory drug, which
works by decreasing the amount of acid the stomach produces.
Clarithromycin and amoxicillin are antibacterial drugs, which
inhibit the growth of bacteria allowing the stomach lining to heal.
Omeclamox-Pak is contraindicated in patients with a history of
hypersensitivity to omeprazole, any macrolide antibiotic or
penicillin. The safety and effectiveness of Omeclamox-Pak in the
pediatric population has not yet been established. For full
prescribing information, visit www.omeclamox.com.
About Cumberland Pharmaceuticals
Cumberland Pharmaceuticals Inc. is a specialty
pharmaceutical company focused on the delivery of high-quality
prescription brands to improve patient care. The Company develops,
acquires, and commercializes brands for the hospital acute care,
gastroenterology, and oncology market segments.
The Company's portfolio of FDA approved brands includes:
- Acetadote® (acetylcysteine) Injection,
for the treatment of acetaminophen poisoning;
- Caldolor® (ibuprofen) Injection, for
the treatment of pain and fever;
- Kristalose® (lactulose) for Oral
Solution, a prescription laxative, for the treatment of chronic and
acute constipation;
- Omeclamox®-Pak, (omeprazole,
clarithromycin, amoxicillin) for the treatment of Helicobacter
pylori (H. pylori) infection and related duodenal ulcer
disease;
- Vaprisol® (conivaptan) Injection, to
raise serum sodium levels in hospitalized patients with euvolemic
and hypervolemic hyponatremia;
- Ethyol® (amifostine) Injection, for
the reduction of xerostomia (dry mouth) in patients undergoing
post-operative radiation treatment for head and neck cancer and the
renal toxicity associated with the administration of cisplatin in
patients with advanced ovarian cancer;
- Totect® (dexrazoxane hydrochloride)
Injection, for emergency oncology intervention, to treat the toxic
effects of anthracycline chemotherapy in case of extravasation
(drug leakage from the bloodstream into the tissues).
Cumberland's pipeline of
product candidates includes:
- Hepatoren® (ifetroban) Injection, a
Phase II candidate for the treatment of critically ill patients
suffering from liver and kidney failure associated with hepatorenal
syndrome ("HRS");
- Boxaban® (ifetroban) Oral Capsules, a
Phase II candidate for the treatment of asthma patients with
aspirin-exacerbated respiratory disease ("AERD");
- Vasculan® (ifetroban) Oral Capsules, a
Phase II candidate for the treatment of patients with systemic
sclerosis (SSc) form of autoimmune disease;
- Portaban® (ifetroban) Injection and
Oral Capsules, a Phase II candidate for the treatment of patients
with portal hypertension associated with liver disease;
- RediTrex™ (methotrexate) Injection, an
approval submission candidate for the treatment of active
rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as
well as severe disabling psoriasis.
For more information on Cumberland's approved products, including full
prescribing information, please visit the individual product
websites, links to which can be found on the Company's website
www.cumberlandpharma.com
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SOURCE Cumberland Pharmaceuticals Inc.